SWITZERLAND AS A THIRD COUNTRY
Switzerland is located in Europe, but it is not an European Union (EU) Member State. It is part of the European Free Trade Association (EFTA) and belongs to the European Economic Area (EEA). EFTA has no legal obligation to follow EU product legislation and trade with Switzerland is established via multiple mutual recognition agreements.
Until now, there was a Mutual Recognition Agreement (MRA) between Switzerland and the EU for the Medical Devices Directive (MDD) and Active Implantable Devices Directive (AIMDD), which allowed medical devices (and other products like machinery and motor vehicles) to move freely between this country and the European Union Market. The EU-Switzerland MRA has previously recognized conformity assessment certificates between the EU and Switzerland based on equivalent regulations. It falls under the scope of the EU-Switzerland Institutional Framework Agreement (InstA) that has been in negotiation between the EU and Switzerland since 2014.
However, this MRA ended because the MDD and AIMDD are no longer applicable and the MRA was not updated. With the full application of the EU Medical Device Regulation (MDR – Regulation (EU) 2017/745, explained in our previous post) on May 26 this year, Switzerland became officially a “third country” to the effects of the EU-MDR. The EU has stated that in the absence of a deal regarding the implementation of the InstA, a full update of the MRA (including the medical devices chapter) cannot be considered.
The MRA has not been updated but it has not been withdrawn, so the EU Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) remains mutually recognized. In 2022 (May 26th), the IVDD will be replaced by the Regulation (EU) 2017/746 (IVDR) and, in the absence of an updated MRA, in vitro medical devices will no longer be covered by the MRA, therefore happening the same as with the non-in vitro medical devices.
CONSEQUENCES IN THE TRADE WITH SWITZERLAND
Until a potential agreement on the proposed modification to the MRA is reached, the trade facilitating effects of the MRA for medical devices falling under the new MDR cease to apply. As a result, this has consequences, particularly when it comes to the mutual recognition of conformity assessment results, the need for an authorized representative and the alignment of technical regulations.
The Swiss Federal Council adopted on May 19th 2021 an amendment to the Swiss Ordinance on Medical Devices (MedDO). This amendment introduces additional requirements to account for the absence of an updated MRA, establishing conditions for trade of medical devices which are covered by EU issued certificates on the Swiss market. The existing certificates (issued under the MRA) by conformity assessment bodies established in the EU are recognized and transitional timelines are granted for the designation of a representative in Switzerland for EU/EEA medical devices manufacturers.
Swiss medium and high-risk devices must be certified by conformity assessment bodies established in the EU. The existing certificates (issued under the MRA) issued by conformity assessment bodies established in Switzerland will no longer be recognized. Switzerland is disputing this EU unilateral determination and defends that transition periods should be given.
Swiss manufacturers, treated now as third country manufacturers, need to appoint a European Authorized Representative so they can export their devices to Europe. On the other hand, European manufacturers must designate a Swiss Authorized Representative to export their products to Switzerland, complying with the Medical Device Ordinance (MedDO). According to the revised MedDO, a Swiss Authorized Representative is “any natural or legal person established within Switzerland who has received a written mandate from a manufacturer located in another country to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligation under this Ordinance”. A Swiss Authorized Representative is required for all medical devices, except for in-vitro medical devices (which are not concerned by the revised MedDO), all procedure packs and all systems.
Economic operators (manufacturers, importers, and authorized representatives) must register with Swissmedic in order to obtain an unique identification number (“Swiss Single Registration Number” – CHRN), within 3 months after placing a device on the market. EUDAMED (EU database on medical devices – see previous post) is not accessible to Swissmedic.
There is still a lot of uncertainty involving the medical devices trade between Switzerland and the EU and how it is going to unfold. One thing is sure, without and updated MRA, Switzerland is regarded as a third country to the effects of the EU MDR and EEA countries are third countries under the Swiss legislation on medical devices.
Critical Catalyst will continue to monitor this situation, assisting Medical Devices companies in the best way possible. If you wish to get more information on this matter or place any questions to our regulatory team, do not hesitate to contact us at info@criticalcatalyst.com.
References:
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02017R0745-20200424&from=EN
- Commission published information notice on the status of the EU-Switzerland Mutual Recognition Agreement for Medical Devices. 26 May 2021. European Commission. Available at: https://ec.europa.eu/commission/presscorner/detail/en/IP_21_2684
